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Deputy Director Process Engineering

Deputy Director Process Engineering

Job Description

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.
The company's heritage, to create vaccines that protect life, dates back more than a century.  Every day, the company invests more than one million Euros in research and development.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
The Deputy Director, Process Engineering, contributes to ensures the technical quality of process engineering activities for strategic capital  projects within the North American Regional GEM Organization, with a focus on projects executed at the Swiftwater site.  This position is required to manage the development of concept, design and fabrication, commissioning and qualification of equipment and systems in a cGMP environment.
This position shall interpret and understand best practices and best-in-class process solutions throughout the North American region, under direction of Regional Automation Engineering Leader, and shall ensure that such practices are considered for projects executed at the Swiftwater site. The position is also a participant in the development and/or technology transfer of new solutions and modifications to existing manufacturing process system while adhering to established regulatory compliance requirements.
The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments; and is accountable for producing a design and then implementing the design (commissioning and qualification) according to GEM best practices
Interpreting process and manufacturing requirements developed by Manufacturing Technology

•         Review/Develop process flow diagrams, mass balances and process descriptions including crtical parameters provided by Manufacturing technology

•         Determine thoroughness to proceed with engineering design

•         Responsible to understand the process requirements and how they impact the process control strategy
Design Development and specifications

•         Develop the overall process engineering strategy for projects, aligning with North American regional best practices and platform standards where possible.

•         Responsible for developing  preliminary and basic engineering deliverables that meet URS and compliance requirements including best practices guidelines

•         Depending on project, some deliverables may be generated internally such as URS, Data-Sheet, mass balance, hydrolic calculations etc.  while other times by external engineering

•         Accountable for technical quality of design. Perform appropriate reviews with stakeholders

•         Work with engineering firm, consultants  or contractors  to design process skids and review vendor designs for adherence to specififcation

•         Participate in PTI reviews. Responsible for design that meets project budget and schedule
Commissioning and qualification

•         Lead C&Q execution for accountable systems

•         Participate in SLA and FCCA.  Review C&Q test plans for technical content. Support mechancial completion and start-up

•         Participate and lead FAT and Critical test plan execution
Technical engineering support to manufacturing sites

•         Provide technical guidance to site engineering teams upon request

•         Apply lessons learned from other sites to help with trouble shooting, design issues and testing specifics. Responsible to understand site specific standards and procedures.
Participate in global networks

•         Contribute lessons learned to the network

•         Participate in global initiatives when requested

•         Responsible to understand current global design guidelines and application
 Ability to effectively communicate with internal and external team members is essential

•         Strong analytical skills (engineering analysis), hands-on troubleshooting skills

•         Ability to work effectively on a team

•         Customer commitment (meet commitments)

Sanofi Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce.  All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.

Job Requirements

Required Qualifications:

•         Minimum University degree, preferably in Chemical Engineering or other technical discipline.

•         Minimum five (5) years hands-on process/design engineering experience in pharmaceutical or biotechnology manufacturing, preferably in a GMP setting

•         Demonstrated ability to manage indirect reports (i.e. support staff , contractors)

•         Understanding of a variety pharmaceutical/biologic bulk API manufacturing processes such as fermentation, CIP/SIP, purification, formulation, filling, and/or packaging.

•         Understanding of GAMP 5, S88, S95, 21 CFR Part 11

Job Snapshot

Employment Type Full-Time
Job Type Engineering, Other
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Healthcare - Health Services, Pharmaceutical, Biotechnology
Required Travel Not Specified
Job ID 00404048-33625
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Deputy Director Process Engineering

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